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Australia TGA Prostheses List Application Preparation and Consulting

ANSWERED ON THIS PAGE:

What is the Australia Prostheses List?

What are the criteria to be eligible for the list?

How can we apply to have our implantable device included on the list?

The Australia Prostheses List (PL) identifies implantable devices eligible for reimbursement from all private health insurance funds. Approximately half of all patients in Australia are treated in the private system, so it is very important that your device is on the Prostheses List to optimize your commercial success in Australia. However, obtaining a PL listing for your device requires a rigorous application and equivalence review process. Emergo can assist with TGA registration and PL applications.

Medical devices eligible for the Prostheses List in Australia

Implantable devices must meet a complex set of criteria to be eligible for the list. To be considered, products must:

Be registered with the TGA and have an Australian Register of Therapeutic Goods (ARTG) number. You can submit a PL application while your TGA approval is pending (see Common Questions below).

Have a code for the applicable surgical procedure performed in a hospital setting.

Remain implanted after the patient is discharged from the hospital.

A detailed list of eligible devices and their criteria are available on the TGA website.

How to apply for the Australia Prostheses List

Manufacturers/importers without a location in Australia are required to appoint a local entity as their Prostheses List Sponsor, which must be the same entity as the Australian Sponsor. Your Prostheses List Sponsor submits your PL application to a Clinical Advisory Committee (CAG), which will assess your application.

The CAG will make a recommendation for the device listing to the Prostheses List Advisory Committee (PLAC) based on its substantial clinical equivalence to previously listed products. Finally, the PLAC makes a final recommendation to the Australian Government.

Our team in Sydney can help with Prostheses Listing applications

Our consulting team in Australia has extensive experience preparing PL applications. When you choose Emergo for your Prostheses List project, we will:

Once submitted, Emergo will continue to work with the clinical advisory groups until your listing is published. It is our goal to get your device listed in the ARTG and PL as quickly and efficiently as possible.

Common questions

When is the list updated?The Prostheses List is updated twice yearly in February and August.

Can we apply for the Prostheses List if our TGA approval is pending?Applications can be submitted at any time, even if TGA approval is pending. If you do not receive TGA approval before the listing update cut off, your device listing will be delayed until the next list.

What is required to include a novel device on the Prostheses List?If there is no suitable predicate for your device, you may apply to create a new grouping. To create a new group, your CAG will expect published results from randomized controlled trials. For benefit determination for a new device, you may be required to submit costing data to the Health Economic Sub Committee of PLAC.

How does the CAG determine reimbursement for our device?Your CAG will allocate your device to groups and subgroups based on its substantial clinical equivalence to previously listed products. The group assignments dictate the reimbursement amount for your product.

Is clinical data required with our PL application?To claim substantial equivalence, you must provide sufficient clinical evidence to support efficacy and cost effectiveness equivalence to other products on the list.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.